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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?


To: David Jones who wrote (2122)2/24/1999 2:11:00 PM
From: Joe  Respond to of 4140
 
David, if you look down to the section entitled REGULATORY MATTERS on page 9, you will find the reference. I don't think this is cause for alarm. I know it happened with BEAM and several of the other laser companies in refractive surgery. I don't think it happened with VISX, but then again, they did not get approval on their first pass because of discrepancies in their clinical data.

Joe



To: David Jones who wrote (2122)2/24/1999 5:44:00 PM
From: RockDoc  Read Replies (1) | Respond to of 4140
 
The filing definitely mentioned it. But SNRS didn't specify exactly what "representations" were made in which particular press release(s) that prompted the letter from from the FDA. As far as I'm concerned , it's not a big deal. I'm sure this stuff happens all the time in dealing with the red tape bureaucratic bs with the FDA.
Next big news will be the announcement of the Ophthalmic Devices Panel meeting. My guess is July instead of May. Their recommendation for approval will be rubberstamped by the FDA and we'll be off to the races. I expect a double in price from here on the day the Panel issues its recommendation. Just my opinion.
The ROCKSTER